文档介绍：我国仿制药申报、审评和研发对策
主要内容
中美关于原研药和仿制药背景
美国仿制药：申报、基于问题审评和研发对策
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中美仿制药研发和申报流程概述专家讲座
第1页
药品经济学催生, clathrate, racemate, or enantiomer of active moiety)
New inactive ingredient that requires more than limited confirmatory studies
Rx OTC switch
New Combination Products
“Generic biologics”
中美仿制药研发和申报流程概述专家讲座
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505(b)(2)排他性
Exclusivities available for 505(b)(2) products
NCE Exclusivity (5 years)
New Product Exclusivity (3 years)
Orphan Drug Exclusivity (7 years)
Pediatric exclusivity extensions (6 months)
Patent Issues
505(b)(2) drugs can have Orange Book-listed patents, and enjoy 30-month stay protection against generic competitors
But, 505(b)(2) NDAs may also be blocked by patents on Reference Drugs
中美仿制药研发和申报流程概述专家讲座
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505(b)(2)新药成功例子
NCE
Thalomid® (thalidomide) (1998)
Marketed unapproved drugs
Levothyroxine ()
Guaifenesin extended release ()
Quinine sulfate ()
New Dosage Form
Tramadol orally disintegrating tablets ()
Ondansetron oral spray (filed )
中美仿制药研发和申报流程概述专家讲座
第14页
505(b)(2)新药例子
New Dosing Regimen
Tramadol extended release tablets ()
New Strength/Formulation
Antara (micronized fenofibrate caps) () (130 mg is BE to Tricor 200 mg)
New Formulation/Inactive Ingredient
Avita (tretinoin gel) (new emollient) (1998)
Abraxane (cremaphor-free paclitaxel) ()
Oxy-ADF (oxycodone formulated to reduce drug abuse) (in development)
中美仿制药研发和申报流程概述专家讲座
第15页
505(b)(2)新药例子
New Active Ingredient
Pexeva (paroxetine mesylate) (new salt) ()
New Route of Administration
Emezine (prochlorperazine) (new buccal/transmucosal delivery) (NDA pending)
Oral amphotericin-B (pre-clinical)
RxOTC Switch
Alavert (loratadine) ()
中美仿制药研发和申报流程概述专家讲座
第16页
505(b)(2)新药例子
“Generic Biologics”
Omnitrope (rHGH) ()
Glucagen (glucagon recombinant) (1998)
Hyaluronidase (various approvals -05)
Fortical (calcitonin salmon recombinant) ()
* Examples based on publicly available information
中美仿制药研发和申报流程概述专家讲座
第17页
FDA NDA 审评过程
中美仿制药研发和申报流程概述专家讲座
第18页
FDA